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| Name | Class |
|---|---|
| The Research Council of Norway | OTHER |
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The goal of this feasibility and pilot study is to investigate the feasibility and preliminary clinical effects of a new rule-based chatbot intervention for adolescents with anxiety symptoms. The main questions are:
Anxiety is one of the most common psychiatric disorders and the anxiety symptoms typically onsets in adolescence. The anxiety symptoms may be persistent into adulthood, leading to a poorer life quality and function impairments. The goal is to prevent the development of anxiety and comorbid disorders, as well as function impairment due to anxiety symptoms. This study wishes to investigate the feasibility and preliminary clinical effects of a digital intervention in an open pre-post and 3 months follow up study. The intervention consists of a rule-based click-chatbot, combined with therapist-guidance. This study will recruit N = 30 adolescents from Norway from age 13 up to 16 years old to investigate the feasibility and preliminary clinical effects of a rule-based click chatbot-intervention, and whether it causes a reduction in anxiety symptoms and increases of life functioning. If the intervention is feasible with promising results, the study will serve as a first step to a future randomized controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile application | Experimental | A six weeks, rule-based chatbot intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rule-based chatbot intervention with therapist-guidance | Other | The intervention is a mobile application designed as a rule-based chatbot. The chatbot will present psychoeducational text, videos and ask questions based on cognitive behavioral techniques. The adolescents will receive weekly therapist support within the mobile application, in addition to weekly contact by phone. The intervention has a duration of six weeks, with a total of six modules. |
| Measure | Description | Time Frame |
|---|---|---|
| Revised Child Anxiety and Depression Scale -47 - Self-report | anxiety and depressive symptoms, higher score indicates worse outcomes | assessing change from screening, pre, immediately after the intervention, follow-up 1 month, and at follow-up 3 months |
| Revised Child Anxiety and Depression Scale - 25 - Self-report | short version of RCADS-47, measuring anxiety and depressive symptoms, with a higher score indicating worse symptoms | assessing change from week 2, and week 4 |
| Revised Child Anxiety and Depression Scale -47 - Parent version | parent-reported anxiety and depressive symptoms, higher score indicates worse outcomes | assessing change from pre, immediately after the intervention, follow-up 1 month, and at follow-up 3 months |
| Revised Child Anxiety and Depression Scale - 25 - Parent version | parent-reported, short version of RCADS-47, measuring anxiety and depressive symptoms, with a higher score indicating worse symptoms | assessing change from week 2, and week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Strengths and Difficulties Questionnaire - Youth version | The scale measure adolescent's general mental health, with a higher score indicating worse symptoms. The study intends to use all three components of the measurement, including 1) the basis of SDQ, which includes 25 items on psychological attributes, 2) impact supplement, measuring functional level. The follow-up version also includes two additional follow-up questions |
| Measure | Description | Time Frame |
|---|---|---|
| Motivation Questionnaire | assessments of their motivation to participate in the intervention, developed specifically for this study | week 2 |
| Evaluation Questionnaire | evaluation assessments of the intervention, developed specifically for this study. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Smiti Kahlon, PhD | Haukeland University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research centre for digital mental health services, Haukeland University Hospital | Bergen | Vestland | 5009 | Norway |
The full protocol and informed consent forms are available upon request. The datasets and the statistical code will not be publicly available, but may be available upon reasonable request through correspondence with principal investigator and according to the Norwegian law and regulations.
starting six months after publication
IPD will be made available from PI on reasonable request and according to relevant Norwegian laws and regulations
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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|
| assessing change from pre, immediately after the intervention, follow up 1 month, and at follow-up 3 months |
| Strengths and Difficulties Questionnaire - Parent version | The scale measure parent-reported adolescent's general mental health, with a higher score indicating worse symptoms. The study intends to use all three components of the measurement, including 1) the basis of SDQ, which includes 25 items on psychological attributes, 2) impact supplement, measuring the adolescents' functional level. The last component is used at follow up which also includes two additional follow-up questions | assessing change from pre, immediately after the intervention, follow up 1 month, and at follow-up 3 months |
| immediately after the intervention |
| Demographics | gender, age | pre-intervention |